Pain Monitoring Using Plurality of Non-invasive Physiological Measurement

This study has been completed.
Sponsor:
Information provided by:
Medasense Biometrics Ltd
ClinicalTrials.gov Identifier:
NCT00914173
First received: June 3, 2009
Last updated: January 27, 2010
Last verified: January 2010
  Purpose

The clinical trial is intended to implement, validate performances and evaluate efficacy of the pain monitoring device for automated assessment of patient's pain level. The efficacy of the pain monitor will be tested by comparing its results to the patient pain reports towards a given pain stimuli.


Condition Intervention
Pain
Device: Scanlaf Circulator and water bath
Device: Medoc TSA 2000

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: A Single-blind Randomized Clinical Trial to Assess the Efficacy of the Medasense's Non-Invasive Pain Monitor in Estimating the Pain Level Comparing to the Pain Stimuli and the Reported Pain Level on Healthy Subjects.

Resource links provided by NLM:


Further study details as provided by Medasense Biometrics Ltd:

Primary Outcome Measures:
  • Comparison between the pain monitoring device results and the subjective pain report measured by the numeric pain scale to a given pain stimulus (heat and cold) [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Collect database to implement the algorithm for the pain monitor to differ between different pain levels. [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pain/No Pain Stimuli
One Arm is used in this trial. The comparator is within the arm. The different types of stimuli levels and types are compared.
Device: Scanlaf Circulator and water bath
Cold Pressor Test
Other Name: Open Cold Water Bath
Device: Medoc TSA 2000
Thermal stimuli pain
Other Name: Medoc Advanced Medical Systems TSA-II System

Detailed Description:

Pain is an unpleasant sensation, ranging from slight discomfort to intense suffering. However, since a great extent of pain is a subjective phenomenon, it has frequently defied objective, quantitative measurement. Traditionally, physicians have had to assess a patient's pain by relying on the patient's own description. Self-description is not only subjective by definition; it is often inaccurate, in part because it is difficult for subjects to precisely articulate their pain while in the midst of a pain experience. Moreover, the report might be impossible when the subject cannot communicate

Presently, in order to quantify pain, the care provider asks the patient to rate his/her pain intensity using one-dimensional scale usually scored from 0 to 10. This scale is known as Numeric Pain Scale. This and other measures are used by the care providers to estimate the correct treatment dose and or to track a treatment progress. Due to its impact on care provider decision to prescribe painkiller mediation, some patients also intentionally misrepresent the existence or extent of their pain. Yet, without any reliable basis for denying such prescriptions, physicians generally must assume that the claims are truthful, even when they may suspect a lack of sincerity. Otherwise, the care provider may be accused of inhumane treatment. Conversely, other patients may underreport their pain, again for a variety of reasons.

The presented clinical trial is intended to implement, validate performances and evaluate efficacy of the pain monitoring device for automated assessment of patient's pain level. During the trial, up to 100 healthy young adults will be voluntarily inflicted by pain stimuli. The pain stimuli will be thermal heat pain stimulus and cold water pain stimulus applied with different intensities. Plurality of Non-Invasive Physiological Measurements will be recorded from volunteers and their Numeric Pain Scale reports will be monitored before, during and after the pain induction. Additional information such as age, gender, ethnicity, etc. will be collected as well. The collected database will be used to implement the algorithm that applies modern signal processing and machine learning methods in order to differentiate between different pain levels. The algorithm will be later integrated into pain monitoring device. The efficacy of the algorithm of the pain monitor will be tested by comparing its results to the patient pain reports towards a given pain stimuli.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy participant that response to pain stimuli
  • Blood Pressure < (90,140), Heart Rate < 100pps
  • Patient informed consent must be obtained

Exclusion Criteria:

  • Not responding to pain stimuli (Hypoalgesia)
  • Over responding to pain stimuli (Hyperalgesia)
  • Classifying non pain stimuli as painful event (Allodynia)
  • Medication/drugs were taken in the last week
  • Usage of chronic medication in the last 3 months (not including contraceptive pills)
  • Alcohol usage during the last 48 hours
  • Caffeine in the last 3 hours
  • Pregnant women
  • Inability to comply with the study protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914173

Locations
Israel
Pain Relief Unit,Rambam Medical Center
Haifa, Israel, 31096
Sponsors and Collaborators
Medasense Biometrics Ltd
Investigators
Principal Investigator: Elon Eisenberg, Prof. Pain Relief Unit, Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Elon Eisenberg, MD, Rambam medical Center -The Pain palliation unit
ClinicalTrials.gov Identifier: NCT00914173     History of Changes
Other Study ID Numbers: Medasense001
Study First Received: June 3, 2009
Last Updated: January 27, 2010
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on October 23, 2014